Does UROSHIELD® Influence Bacterial Growth On Endotracheal Tubes

NCT ID: NCT02074306

Last Updated: 2018-08-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-12-31

Brief Summary

The purpose of this study is to examine the effect of UROSHIELD® (a device which generates low energy ultrasound waves) on development of bacterial colonies on endotracheal tubes, in patient receiving mechanical ventilation, and to determine whether this device lowers the rate of bacterial resistance to antibiotics.

Detailed Description

Ventilator Associated Pneumonia (VAP) is a common complication in patients treated by mechanical ventilation, supposedly related to development of bacterial colonization on the endotracheal tubes. Therefore many devices were designed to address this issue.

NanovibronixTM Company developed "UROSHIELD®" a device which generates low energy ultrasound wave in the nanometer range, and delivers these waves by an actuator which is connected externally to a urinary catheter. It was shown that using UROSHIELD®, there was reduction in development of bacterial colonies, and lower rate of resistance of bacteria to antibiotics.

Aim of the study:

To examine the effect of UROSHIELD® on development of bacterial colonies on endotracheal tubes, in patient receiving mechanical ventilation, and to determine whether this device lowers the rate of bacterial resistance to antibiotics.

Methods:

Consecutive patients, with newly begun mechanical ventilation, will be connected to UROSHIELD® within 48 hours. Endotracheal secretions will be collected for culture and antibiotic sensitivity every 3 days for 15 consecutive days or until disconnection from the mechanical ventilation. Half of the devices will be active for the study group; the other half will be sham for the control. The devices will externally look identical and will have a serial number which will remain secret.

Primary end point: The time to convert the sputum culture from negative to positive.

Secondary end points: The number of positive cultures with virulent bacteria and the rate of development of resistance to antibiotics will also be compared.

By statistical analysis the investigators conclude that enrollment of 33 patients into each group will allow significant results to be detected.

Should the study group show longer time to convert to positive bacterial culture and/or lower antibiotic resistance, the use of UROSHIELD®, should be examined in a larger study, with reduction of VAP as a primary end point.

Conditions

Mechanical Ventilation Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

UROSHIELD®

Randomly selected patients,(ratio 1:1) with newly begun mechanical ventilation, will be connected to a low energy acustic wave generator UROSHIELD® within 48 hours. Endotracheal secretions will be collected for culture and antibiotic sensitivity every 3 days for 15 consecutive days or until disconnection from the mechanical ventilation.

Group Type: EXPERIMENTAL

UROSHIELD®

Intervention Type: DEVICE

An active UROSHIELD® device (low energy acustic wave generator) will be connected to an intratracheal tube externally. The device will transform low energy ultrasound waves on to the tube. These waves will by assumption lower the formation of bacterial growth and resistance to antibiotics.

SHAM UROSHIELD®

same as abouve but with Sham device.

Group Type: SHAM_COMPARATOR

SHAM UROSHIELD®

Intervention Type: DEVICE

SHAM UROSHIELD® will be connected to endotracheal tubes unable to transform any waves.

Interventions

UROSHIELD®

An active UROSHIELD® device (low energy acustic wave generator) will be connected to an intratracheal tube externally. The device will transform low energy ultrasound waves on to the tube. These waves will by assumption lower the formation of bacterial growth and resistance to antibiotics.

Intervention Type: DEVICE

SHAM UROSHIELD®

SHAM UROSHIELD® will be connected to endotracheal tubes unable to transform any waves.

Intervention Type: DEVICE

Other Intervention Names

LUNGSHIELD®; SHAM LUNGSHIELD®

Eligibility Criteria

Inclusion Criteria

• Consecutive adult patients, with newly begun mechanical ventilation, will be connected to UROSHIELD® within 48 hours

Exclusion Criteria

• Pediatric patients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shaare Zedek Medical Center

OTHER

Sponsor Role: lead

Responsible Party

REUVEN FRIEDMANN

head of geriatric ward

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Reuven Friedmann, Dr

Role: STUDY_DIRECTOR

Shaare Zedek Medical Center

Locations

Medical wing, Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Reuven Friedmann, Dr

Role: CONTACT

reufri@szmc.org.il

+972508685156

Facility Contacts

Reuven Friedmann, Dr

Role: primary

reufri@szmc.org.il

972508685156

Other Identifiers

SZMCenter IRB

Identifier Type: OTHER

Identifier Source: secondary_id

109/13

Identifier Type: -

Identifier Source: org_study_id